A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery

This is an interventional diagnostic trial for Sentinel Lymph Node Biopsy focused on measuring ASP5354, pudexacianinium chloride, SLN, Breast Cancer, Melanoma Read More

Inclusion Criteria:

• Participant has been diagnosed with localized breast cancer (female only, stage 1 to 2, N0 and M0) or melanoma (stage 1 to 2, N0 and M0) and is scheduled to undergo surgical intervention for systemic lymph node (SLN) detection and removal using Technetium-99m sulfur colloid or Lymphoseek as part of Standard of Care (SOC).

• Female participant is not pregnant and at least 1 of the following conditions apply:

  • Not a woman of childbearing potential (WOCBP)
  • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final study treatment administration.
• Female participant must not donate ova starting at first dose of Investigational Product (IP) and throughout the study period and for 30 days after final study treatment administration.
• Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use of contraception throughout the treatment period and for 30 days after final study treatment administration.
• Male participant must not donate sperm during the treatment period and for 30 days after final study treatment administration.
• Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
• Participant agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

• Participant has had prior lymph node (LN) surgery in the area where LN detection is needed.
• Participant has had prior LN radiation in the area where LN detection is needed.
• Participant has had prior neo-adjuvant chemotherapy.
• Participant has definitive LN metastases.
• Participant has metastatic cancer.
• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Participant has any condition which makes the participant unsuitable for study participation.
• Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
• Participant has had previous exposure to ASP5354.
• Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that would impact safety or study compliance.
• Participant has a resting heart rate <= 45 beats per minute (bpm) or >=115 bpm, systolic blood pressure >=160 mm Hg or diastolic blood pressure >= 100 mm Hg within 1 week prior to IP administration. If the blood pressure exceeds the limits above, repeat readings can be taken. Participant who has adequately controlled blood pressure is eligible.
• Participant has any of the screening laboratory values outside of the protocol specification criteria.
• Participant has received ICG, other near-infrared fluorescence (NIR-F) imaging agents, Blue dye (e.g., methylene blue or isosulfan blue) or magtrace within 2 weeks prior to IP administration.
• Participant has active alcohol abuse or illicit drug use (non-prescription or over-the-counter medications). Participant should not have consumed any alcohol or illicit drug (excluding cannabidiol products) within 24 hours of surgery.